Comparison Between the Effect of Ultrasound Debridement and Conventional Treatment in Diabetic Foot Ulcers (DFU).

Randomized Clinical Trial to Elucidate the Effects of Low Frequency Ultrasound Debridement (LFU), in Patients With Diabetic Foot Ulcers, Compared to Its Conventional Treatment

The investigators aimed to elucidate the effects of ultrasound debridement on the area and healing of diabetic foot ulcers compared to their conventional treatment.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Procedure: Ultrasound Debridement; Procedure: Conventional Treatment

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sebastián Flores Escobar; Phone Number: +34 667857971; Email: jhflores@ucm.es
• Study Contact Backup: Name: Francisco Javier Alvaro Afonso; Phone Number: +34 91 394 1535; Email: alvaro@ucm.es

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Complutense University
    • Contact: Sebastián Flores; Phone Number: +34 667857971; Email: jhflores@ucm.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female patients ≥18 years old.
• Type 1 or type 2 diabetes mellitus with HbA1c ≤ 10%.
• DFU grades IA, IIA, IB, IIB, IC, IIC, ID, IID, according to the University of Texas Classification.
• DFU grades PEDIS 1-Absence of Infection, PEDIS 2-Mild infection and PEDIS 3-Moderate infection, according to the PEDIS-IDSA Classification.
• Wound size between 1 cm² and 30 cm².
• Evolution time DFU between 1 and 24 months.
• Ankle-brachial index (ABI) ≤0.9 and ankle systolic blood pressure (ASBP) ≥70mmHg, or toe systolic blood pressure (TSBP) ≥50mmHg, ABI>0.9, TSBP ≥50mmHg and toe-brachial index (TBI) ≤0.7

Exclusion Criteria:

• Critical limb ischemia patients with ABI≤0.5 and ASBP<70mmHg or TSBP<50mmHg.
• Clinical suspicion of osteomyelitis.
• Pregnant or lactating women or women of childbearing potential who are not using effective contraception.
• Patients diagnosed with hepatitis or human immunodeficiency virus (HIV)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ultrasounds once a week; Patients will undergo the application of ultrasound therapy with a frequency of once a week.	Procedure: Ultrasound Debridement; Ultrasounds debridement is performed using an SONOCA 185 device (Söring GmbH, Germany). The ultrasounds device generates an ultrasound low frequency of 25kHz and is equipped with three instruments with different sonotrode shapes. The choice of sonotrode depends on wound depth. The ultrasounds instrument piezoelectrically transforms the electrical energy delivered from the ultrasound device into mechanical oscillations in the sonotrode tip.
EXPERIMENTAL: Ultrasounds once every two weeks; Patients will undergo the application of ultrasound therapy with a frequency of once every two weeks.	Procedure: Ultrasound Debridement; Ultrasounds debridement is performed using an SONOCA 185 device (Söring GmbH, Germany). The ultrasounds device generates an ultrasound low frequency of 25kHz and is equipped with three instruments with different sonotrode shapes. The choice of sonotrode depends on wound depth. The ultrasounds instrument piezoelectrically transforms the electrical energy delivered from the ultrasound device into mechanical oscillations in the sonotrode tip.
ACTIVE_COMPARATOR: Standard of care; Patients will be treated using the conventional treatment established by the protocol of the Diabetic Foot Unit of the University Podiatry Clinic of Complutense University of Madrid.	Procedure: Conventional Treatment; Conventional Treatment based on international guidelines for diabetic foot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing Rate	Total epithelialization of the wound.	12 weeks
Healing Time	Time from the inclusion of the wound in the study until its total epithelialization.	12 weeks
Wound Size	Planimetric measurements of wound size will be made using Visitrak (Smith & Nephew, Hull, UK).	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Conditions	The wound bed tissue will be evaluated for the presence, quality and consistency of the granulation tissue using a validated wound scoring system, with scores ranging from a minimum of zero points to a maximum of seven points (Wollina Score).	12 weeks
Transcutaneous oxygen pressure (TcPO2)	Two measurements will be made, one at the initial visit and the other at the final visit, and possible variations will be assessed.	baseline and week 7
Pain intensity	It will be assessed using a numerical scale of pain that receives values between zero and ten, understanding zero as the absence of pain and ten as the maximum pain bearable by the patient	12 weeks
Health-related quality of life	It will be assessed using the SF-36 health-related quality of life questionnaire at the beginning and end of the study. This questionnaire receives values between zero and one hundred so that the higher the score, the better the patient's health status.	baseline and 12 week

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Collaborators: Yolanda García Álvarez; Francisco Javier Álvaro Afonso
• Investigators: Principal Investigator: Yolanda García Álvarez, Complutense University of Madrid

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2021
• Primary Completion (ANTICIPATED): January 18, 2022
• Study Completion (ANTICIPATED): June 23, 2023

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (ACTUAL): January 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Diabetic Foot Ulcer; Diabetic Foot; Ultrasound Debridement; Ultrasonic Debridement
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: Ultrasound Debridement; 20/738-EC_P (OTHER: Ethics Committee of the Hospital Clínico San Carlos)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No